Brief Job Overview:This is a hands-on, non-supervisory position in USP's Reference Standards Laboratory. The incumbent will provide technical assistance to collaborative testing and the continued suitability for use program by performing analytical tests, reviewing analytical data, and preparing summary reports. The incumbent may execute 90% - 100% of their work at the bench level.
The Scientist III has the following responsibilities:- 75% of time in laboratory duties
- Performs routine drug release testing and chemical analysis on developmental formulation and candidate reference materials; examples of test procedures include USP UV-Vis analyses, Loss on Drying, Karl Fischer titrations, Disintegration, Hardness testing, Friability, Differential scanning calorimetry (DSC)/ Thermogravimetric analysis (TGA), particle size determination by laser diffraction, liquid chromatography; Prepares solutions and reagents as needed.
- Participates in cross-functional teams involved in reference standards development, including test protocol generation and review.
- Conducts research into processes and techniques of relevance to pharmaceutical dosage form in vitro testing and dosage for performance characterization.
- Provides and assists in technical and professional training of lab staff members.
- 25% other laboratory duties
- Define critical processes and workflows of projects.
- Implement data collection systems and databases.
- Assess protocol effectiveness and develop recommendations for improvement.
- Develops and validates analytical methods.
- Coordinates activities among the team members and communicates results of work.
- Assists in planning, research, and development required for all projects.
- Prepares and presents oral and written reports.
- Provides project and technical support including managing project tasks via interacting with internal and external clients, other departments and USP customers to create an achievable work schedule.
- Serves as a mentor for scientists in the laboratory regarding technical knowledge, work ethics, and attitude.
- Initiates and coordinates issue management when necessary, using Master Control, or equivalent issue management software.
- Prepares evaluation reports and presents data internally within USP and externally to customers and stakeholders.
- Serves as the technical lead for investigations, corrective action plans and implementation of corrective actions.
- Troubleshoots methods and instrumentation issues. This will involve data mining, trending and analysis to identify problems or determine process controls necessary to mitigate risks to data quality.
- Conducts scientific seminars and presents scientific work.
- Reviews, interprets, and evaluates available scientific literature.
- Investigates, evaluates, and recommends the purchase of laboratory equipment.
Who is USP Looking For?The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
Qualifications:• Ph.D. in Chemistry or related field, or
• M.S. in Chemistry or related field and 5 years of experience evaluating drug product performance and quality, or
• B.A./B.S. in Chemistry or related field and 10 years of experience evaluating drug product performance and quality.
Additional Desired Preferences:• Must have the capability to plan and conduct research independently.
• Familiarity with the cGMP and/or ISO requirements for testing laboratories is required.
• Research experience in dosage form characterization and in vitro testing is required.
• Previous project management experience.
• Excellent communication and presentation skills, both verbal and written.
• Proficient with drug release and product testing involving compendial methods (USP, BP, EP, etc.).
• Accepts personal responsibility to ensure the work is delivered on time and is of the highest quality.
• Skilled in anticipating, troubleshooting and solving technical problems.
• Possesses ability to build technical expertise in others by serving as a role model and positive influence on the team.
• Possesses experience and a proven track record of introducing new or innovative technologies into the laboratory.
• Proven analytical and multi-tasking abilities.
Supervisory Responsibilities: None, this is an individual contributor role.
Benefits:USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
Compensation:Base Salary Range: USD $86,860.00 - $117,017.50 annually.
Target Annual Bonus: % Varies based on level of role
Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
Third-Party Recruiters: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Note: As part of the recruitment process, USP's Global Talent Acquisition team may contact candidates through a variety of communication channels, including Microsoft Teams, telephone, email, and WhatsApp (voice calls and text messages). These communications may be used to schedule interviews,
provide updates on application status, discuss career opportunities, and answer questions about employment with USP.
To help ensure timely communication, candidates are encouraged to keep their contact information current and to engage only with individuals who clearly identify themselves as authorized USP representatives. USP will never request payment, banking details, or other financial information as part of the hiring process.
Fraud Alert: USP is committed to protecting job seekers from recruitment fraud. Legitimate employment-related communications will come only from authorized USP representatives. If you are unsure whether a communication is authentic, please verify it through USP's official careers website before sharing personal information.
